Critical Limb Ischemia Treatment Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

The critical limb ischemia treatment market is anticipated to grow with a CAGR of nearly 8.3% over the forecast period.

The COVID-19 pandemic had a significant impact on the healthcare systems with significant consequences for not only COVID-19-infected patients but also others, resulting in the cancellation of diagnostic and treatment procedures. For instance, according to an article published by the Internal Journal of Surgery Case Reports in March 2021, hospitals deferred elective procedures, venous surgeries, and the treatment of asymptomatic conditions requiring intervention, thus impacting the market growth. Additionally, according to a study published in the Journal of Vascular Surgery in August 2021, the SARS-CoV-2 infection had been linked to an increased risk of thrombotic complications, including limb ischemia. COVID-related limb ischemia appeared in individuals with a low incidence of comorbidities and was associated with a high death and amputation risk. As a result, the increased risk of limb ischemia associated with COVID-19 infection substantially impacted the market. However, currently, the market is growing at a stable pace owing to a resumption of surgical procedures and it is expected to witness a similar trend over the coming years.

Certain factors that are propelling the market growth are the increasing prevalence of critical limb ischemia and the improvement in healthcare infrastructure.

The significant burden of critical limb ischemia is expected to propel the growth of the market. For instance, according to a June 2022 study published in the Journal of Clinical Medicine, the mean annual incidence of chronic limb-threatening ischemia (CLTI) in New Zealand (NZ) was 36.2 per 100,000 people in 2021. Men had a higher annual incidence of CLTI conditions. Thus, this is expected to rise in demand for its treatment, thereby boosting the market growth.

Additionally, the growing prevalence of the risk factors which increase CLI incidence is expected to boost the growth of the market. For instance, according to an article published by the Korean Circulation Journal in June 2021, it has been observed that the obese and underweight groups are more likely to experience critical limb ischemia and infrapopliteal artery disease. According to the WHO European Regional Obesity report 2022, overweight and obesity have reached epidemic proportions in the WHO European Region, impacting about 60% of individuals. Children are also affected with 7.9% of children under the age of 5 and one out of every three school-aged children being overweight or obese. Alarmingly, there have been consistent increases in the prevalence of overweight and obesity in the WHO European Region and no Member State is on track to reach the target of halting the rise in obesity by 2025. This is expected to increase the demand for critical limb ischemia treatment, thereby fueling the market growth.

Furthermore, various strategies adopted by the market players such as product launches, mergers and acquisitions, and product development are expected to support the market's expansion over the forecast period. For instance, in May 2022, Filterlex Medical Ltd., a cardiovascular medical device firm, announced the positive results of a first-in-human (FIH) trial demonstrating the CAPTIS device's safety, practicality, and performance. CAPTIS is a next-generation, full-body embolic protection device that minimizes the risk of stroke and other complications during left-heart surgery by releasing embolic particles into the bloodstream. Hence, such studies are likely to contribute to the market growth over the forecast period.

However, stringent regulatory guidelines and an increasing number of recalls may restrain the market growth.

Critical Limb Ischemia Treatment Market Trends

Embolic Protection Devices Segment Expects to Register a High CAGR over the Forecast Period

Embolic protection devices (EPDs) are medical devices used to prevent or reduce plaque debris from reaching the distal bed. They are commonly used in saphenous vein graft (SVG) interventions and during carotid artery stenting procedures. The embolic protection devices segment is expected to witness significant growth in the critical limb ischemia treatment market over the forecast period.

The factors propelling the growth of embolic protection devices are the higher adoption of these devices as it prevents distal embolization and lower clinical complications by capturing and removing thrombus/debris while performing surgical procedures. For instance, according to an article published by Cardiovascular Interventional Radiology, in May 2021, it has been found that the Spider FX embolic protection device was safe and effective in capturing embolic debris during femoropopliteal interventions. Thus, the increased safety and efficacy of these devices are expected to increase the usage of these devices in treating critical limb ischemia, thereby boosting the market growth.

Furthermore, the rising company activities for developing bone graft substitute products and the rising adoption of various business strategies such as collaborations, mergers, and acquisitions are all anticipated to increase the market growth over the forecast period. For instance, in May 2021, Emboline raised USD 55 million in a Series D investment transaction. This investment will support a planned US-based pivotal trial for FDA approval as well as investigational studies for new indications, and manufacturing and commercial operations for the Emboliner, a device designed to give total embolic protection by catching and eliminating all debris during transcatheter treatments.

North America Dominates the Market and is Expected to do Same over the Forecast Period

North America is expected to dominate the overall critical limb ischemia treatment market throughout the forecast period. The factors that propel the market growth are the high prevalence of critical limb ischemia patients and the presence of key market players.

The rising burden of critical limb ischemia, along with risk factors such as obesity, diabetes, hypertension, and hyperlipidemia among the population, is the key factor driving the demand for the studied market over the forecast period. Patients with diabetes are at increased risk of developing chronic limb-threatening ischemia (CLTI) due to peripheral arterial disease, and an increase in the prevalence of diabetes is expected to boost market growth. For instance, according to 2022 statistics published by the International Diabetes Federation, in the 10th edition of 2021, 32 million people were living with diabetes in the United States, and this number is projected to reach 34 million by 2030 and 36 million by 2050. High blood sugar caused by diabetes can damage the nerves that control the heart and blood vessels, leading to a variety of arterial diseases which can narrow the arteries. This is expected to increase the demand for effective treatment, thereby boosting the market growth.

Moreover, the increasing focus of the company to develop technologically advanced devices and drugs to treat critical limb ischemia is expected to augment the growth of the market. For instance, in May 2022, the US FDA approved Medtronic’s IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, a drug-coated balloon (DCB), for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. Additionally, in January 2022, Cook Medical received the Breakthrough Device designation from the US FDA on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI).

Critical Limb Ischemia Treatment Market Competitor Analysis

The critical limb ischemia treatment market is moderately competitive and consists of several major players. The companies are adopting various business strategies such as product launches, collaborations, funding, and others to withhold their position in the market and enter the critical limb ischemia market. Some of the key players in the studied market are Medtronic plc, Abbott Laboratories, Rexgenero Ltd., LimFlow SA, Cardiovascular Systems, Inc., Eli Lilly and Company, and ThermoGenesis Holdings, Inc

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